Principal Scientist, Analytical Development - Gene Therapy

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Development Analytical Development group at Lilly Harborside Laboratories is seeking a Scientist to provide analytical assay development, optimization and routine testing of AAV viral vectors. The ideal candidate will have experience with characterizing AAV viral vectors, executing analytical assays, working collaboratively and preparing necessary technical documents. The successful candidate will have a desire to succeed at the highest level to develop therapies that have the potential to restore and preserve hearing.

Job Responsibilities

• Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. Makes sound technical decisions, and appropriately communicates these decisions to other scientists and management.
• Efficiently and effectively handles project deliverables to provide support for multiple projects at multiple phases. May serve as the project lead for one or multiple projects within the area.
• Demonstrates technical excellence at performing and assessing multiple analytical methods.  Displays comprehensive knowledge of instrument set-up, operation, and troubleshooting (e.g., AUC, Bioassay, ELISA, Vector Genome Titer)
• Perform routine analytical and in vitro bioassays to characterize product quality, strength, and potency.
• Document analysis according to good documentation practices in Lilly Harborside Laboratories electronic laboratory notebook or other documentation methods such as test data worksheets or other prescribed methods.

Basic Qualifications:

• Bachelor’s degree with 10+ years OR Master’s degree with 8+ years of relevant industry experience in analytical development, molecular biology, biochemistry, chemistry, biotechnology, chemical engineering, or a closely related field.
• Demonstrated experience leading analytical method development, qualification, validation, transfer, and lifecycle management in a regulated environment (e.g., GMP) supporting gene therapy or advanced modalities.
• Consistent track record supporting early- and late-stage development, comparability, regulatory submissions, and/or commercial readiness for viral vector or gene therapy programs.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Skills and Preferred Qualifications:

• Strong ability to work independently while also mentoring and guiding junior scientists in a collaborative, cross-functional environment.
• Extensive experience developing and executing potency and functional assays for gene therapy products, including cell-based bioassays relevant to mechanism of action.
• Hands-on experience with ELISA, cell-based assays, and analytical ultracentrifugation (AUC) to support viral vector characterization, potency, and stability.
• Experience with molecular and biochemical techniques relevant to gene therapy, such as qPCR, ddPCR, vector genome quantification, capsid characterization, and impurity analysis is highly preferred.
• Working knowledge of viral vector platforms such as adeno-associated virus (AAV) and production models such as HEK293 or Bac/SF9.
• Experience defining critical quality attributes and developing phase-appropriate analytical strategies aligned with regulatory expectations.
• Demonstrated leadership in technical strategy, risk assessment, and decision-making, with the ability to influence program direction.
• Experience managing external collaborations with CROs, CDMOs, and testing laboratories.
• High level of attention to detail and dedication to data integrity, compliance, and quality standards.
• Experience with mammalian cell culture, aseptic techniques, and viral vector handling is preferred.
• Proven ability to manage multiple priorities and deliver results in a fast-paced and evolving environment.